A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

Официальное название

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors

Обзор

This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.

Вмешательства

• Препарат ANS014004
  Varying doses of ANS014004

Первичные конечные точки

• Incidence of Adverse Events (AEs) [Срок оценки: From the time of first dose to 28 days post last dose of ANS014004]
• Incidence of Serious Adverse Events (SAEs) [Срок оценки: From time of first dose to 28 days post last dose of ANS014004]
• Incidence of dose-limiting toxicities (DLT) as defined in the protocol [Срок оценки: From time of first dose of ANS014004 to end of DLT period (approximately 30 days)]
• Incidence of baseline laboratory finding, ECG and vital signs changes [Срок оценки: From time of first dose to 28 days post last dose of ANS014004]
• Proportion of patients with radiological response (ORR) [Срок оценки: From date of first dose of ANS014004 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)）]

Вторичные конечные точки (11)

• Objective Response Rate (ORR) [Срок оценки: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
• Duration of Response (DoR) [Срок оценки: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
• Disease Control Rate (DCR) [Срок оценки: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
• Progression free Survival (PFS) [Срок оценки: rom date of first dose of ANS014004 up until date of progression or death due to any cause (approximately 2 years)]
• Overall Survival (OS) [Срок оценки: From date of first dose of ANS014004 up until the date of death due to any cause (approximately 2 years)]
• Pharmacokinetics of ANS014004: Plasma PK concentrations [Срок оценки: From date of first dose up until 28 days post last dose]
• Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC) [Срок оценки: From date of first dose up until 28 days post last dose]
• Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max) [Срок оценки: From date of first dose up until 28 days post last dose]
• Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max) [Срок оценки: From date of first dose up until 28 days post last dose]
• Pharmacokinetics of ANS014004: Clearance [Срок оценки: From date of first dose up until 28 days post last dose]
• Pharmacokinetics of ANS014004: Half-life [Срок оценки: From date of first dose up until 28 days post last dose]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
• Life expectancy ≥ 12 weeks
• Measurable disease per RECIST v1.1
• Adequate organ and marrow function as defined in the protocol
• With a pathogenetic MET alteration or ROS1 alteration or NTRK alternation

Критерии исключения

• Active infection including tuberculosis and HBV, HCV or HIV
• Known active or untreated CNS metastases
• Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
• Participants with serious cardiovascular or cerebrovascular diseases

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 8 центров

• University of California, San Diego — San Diego
• Sarah Cannon Research Institute — Denver
• Advent Health — Orlando
• Henry Ford Health Cancer — Detroit
• NYU Langone Health — New York
• The University of Texas - MD Anderson Cancer Center — Houston
• NEXT Oncology, Virginia — Fairfax
• Swedish Cancer Institute — Seattle

Китай · 5 центров

• Beijing Chest Hospital — Пекин
• Harbin Medical University Cancer Hospital — Харбин
• Henan Cancer Hospital — Чжэнчжоу
• Shandong Cancer Hospital — Цзинань
• Shanghai Chest Hospital — Шанхай

Канада · 2 центра

• BC Cancer Vancouver Centre — Vancouver
• Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT06307795 · ANS014004-I-US-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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